Status:
Recruiting
Disease Site:
Ovarian
Phase:
Official Title:
NRG-GY019, RANDOMIZED PHASE III STUDY OF CARBO/TAXOL/MAINTENANCE LETROZOLE VERSUS LETROZOLE MONOTHERAPY IN PATIENTS WITH STAGE II-IV, PRIMARY LOW-GRADE SEROUS CARCINOMA OF THE OVARY OR PERITONEUM
NCT ID:
NCT#04095364
Link to Full Details:
Description:
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
Eligibility:
Female – 18 years and older
Inclusion Criteria:
- Newly Dx, Stage II-IV low-grade serous carcinoma
- TP53 must be nonaberrant